A Clinical Study of Intismeran Autogene (V940) Plus Pembrolizumab in People With High-Risk Melanoma (V940-001)

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

1,089

Participants

Timeline

Start Date

July 19, 2023

Primary Completion Date

October 26, 2029

Study Completion Date

September 26, 2030

Conditions
Melanoma
Interventions
BIOLOGICAL

Intismeran autogene

IM injection

BIOLOGICAL

Pembrolizumab

IV infusion

OTHER

Placebo

IM injection

Trial Locations (165)

704

National Cheng Kung University Hospital-Clinical Trial Center ( Site 4004), Tainan City

1023

Harbour Cancer & Wellness ( Site 1500), Auckland

1090

UZ Brussel-Medische oncologie ( Site 3405), Brussels

2065

Melanoma Institute Australia-Clinical Trials Unit ( Site 1000), Wollstonecraft

2145

Westmead Hospital ( Site 1001), Westmead

2196

Medical Oncology Centre of Rosebank ( Site 4106), Johannesburg

2730

Herlev and Gentofte Hospital ( Site 3301), Copenhagen

3000

Peter MacCallum Cancer Centre-Parkville Cancer Clinical Trials Unit (PCCTU) ( Site 1005), Melbourne

UZ Leuven ( Site 3400), Leuven

3004

Paula Fox Melanoma & Cancer Centre ( Site 1004), Melbourne

3600

Ziekenhuis Oost-Limburg, Campus St.-Jan ( Site 3402), Genk

4102

Princess Alexandra Hospital ( Site 1003), Brisbane

5000

Odense Universitetshospital ( Site 3300), Odense C

6009

One Clinical Research ( Site 1002), Nedlands

6021

Capital, Coast and Hutt Valley District - Wellington Regional Hospital ( Site 1502), Newtown

7000

Kantonsspital Graubünden-Medizin ( Site 1703), Chur

7570

Cape Town Oncology Trials ( Site 4100), Cape Town

8058

UniversitätsSpital Zürich-Dermatology ( Site 1700), Zürich Flughafen

8500

AZ Groeninge Campus Kennedylaan-Oncology ( Site 3401), Kortrijk

9000

UZ Gent ( Site 3403), Ghent

Aalborg Universitetshospital, Syd ( Site 3302), Aalborg

10002

National Taiwan University Hospital ( Site 4001), Taipei

10016

NYU Langone Health-Perlmutter Cancer Center ( Site 1917), New York

10032

Columbia University Irving Medical Center-CUIMC Herbert Irving Comprehensive Cancer Center Clinical ( Site 1908), New York

10065

Memorial Sloan Kettering Cancer Center ( Site 1914), New York

10115

Charité Universitaetsmedizin Berlin - Campus Mitte-Hauttumorcentrum Charité (HTCC) ( Site 1302), Berlin

11501

Perlmutter Cancer Center at NYU Langone Hospital - Long Island ( Site 1958), Mineola

13385

Assistance Publique Hôpitaux de Marseille - Hôpital de la Ti-Service de Dermatologie et Cancérologi ( Site 1203), Marseille

15232

UPMC Hillman Cancer Center ( Site 1909), Pittsburgh

18057

Universitätsmedizin Rostock-Klinik und Poliklinik für Dermatologie und Venerologie ( Site 1310), Rostock

19104

Hospital of the University of Pennsylvania Perelman Center for Advanced Medicine ( Site 1905), Philadelphia

20133

Fondazione IRCCS Istituto Nazionale dei Tumori ( Site 1401), Milan

20141

Istituto Europeo di Oncologia IRCCS ( Site 1404), Milan

20246

Universitaetsklinikum Hamburg-Eppendorf ( Site 1309), Hamburg

21079

Centre Georges François Leclerc ( Site 1210), Dijon

21287

Johns Hopkins Hospital-Sidney Kimmel Comprehensive Cancer Center - Melanoma ( Site 1912), Baltimore

22031

Inova Schar Cancer Institute ( Site 1900), Fairfax

22185

Skånes Universitetssjukhus Lund ( Site 3201), Lund

25030

CHU Besançon ( Site 1209), Besançon

27599

University of North Carolina Medical Center-Lineberger Comprehensive Cancer Center ( Site 1949), Chapel Hill

27710

Duke Cancer Institute ( Site 1911), Durham

28034

Hospital Universitario Ramón y Cajal ( Site 1602), Madrid

28223

HOSPITAL UNIVERSITARIO QUIRONSALUD MADRID ( Site 1603), Pozuelo de Alarcón

29011

H.R.U Málaga - Hospital General-Oncology ( Site 1605), Málaga

29425

Medical University of South Carolina-Hollings Cancer Center ( Site 1934), Charleston

30060

Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital ( Site 1950), Marietta

30322

Winship Cancer Institute of Emory University ( Site 1940), Atlanta

32429

Johannes Wesling Klinikum Minden-Skin Cancer Center Minden ( Site 1301), Minden

32806

Orlando Health Cancer Institute ( Site 1937), Orlando

33075

CHU de Bordeaux Hop St ANDRE-Service de Dermatologie ( Site 1204), Bordeaux

33305

Chang Gung Medical Foundation-Linkou Branch ( Site 4003), Taoyuan District

33612

Moffitt Cancer Center, Richard M. Shulze Family Foundation Outpatient Center ( Site 1945), Tampa

34303

Acibadem Universitesi Atakent Hastanesi-Medical Oncology ( Site 3008), Istanbul

34722

TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi-oncology ( Site 3003), Istanbul

35015

Chungnam national university hospital-Department of Internal Medicine ( Site 3903), Daejeon

35042

Centre Eugène Marquis Rennes - Centre de Lutte Contre le Cancer ( Site 1206), Rennes

35100

Ege University Medical Faculty Hospital ( Site 3011), Izmir

35575

I.E.U. Medical Point Hastanesi-Oncology ( Site 3005), Izmir

37075

Universitätsmedizin Göttingen - Georg-August-Universität-Dermatology ( Site 1308), Göttingen

37203

SCRI Oncology Partners ( Site 1910), Nashville

41404

Kyungpook National University Chilgok Hospital-Hematology/oncology ( Site 3904), Daegu

45147

Universitaetsklinikum Essen-Klinik für Dermatologie, Venerologie und Allergologie ( Site 1300), Essen

46010

HOSPITAL CLINICO DE VALENCIA ( Site 1604), Valencia

48109

University of Michigan ( Site 1915), Ann Arbor

49503

Cancer and Hematology Centers of Western Michigan ( Site 1932), Grand Rapids

50937

Universitaetsklinikum Koeln ( Site 1307), Cologne

52242

University of Iowa-Holden Comprehensive Cancer Center ( Site 1935), Iowa City

53100

Azienda Ospedaliero Universitaria Senese-U.O.C. Immunoterapia Oncologica ( Site 1402), Siena

57104

Sanford Cancer Center ( Site 1951), Sioux Falls

59037

Hopital Claude Huriez - CHU de Lille ( Site 1207), Lille

66424

Universitaetsklinikum des Saarlandes ( Site 1313), Homburg

68167

Universitätsmedizin Mannheim ( Site 1305), Mannheim

69310

centre hospitalier lyon sud-Service de dermatologie ( Site 1202), Pierre-Bénite

72762

Highlands Oncology Group ( Site 1943), Springdale

75010

Hôpital Saint-Louis ( Site 1200), Paris

75246

Texas Oncology - Dallas (Sammons) ( Site 1902), Dallas

77030

University of Texas MD Anderson Cancer Center ( Site 1920), Houston

78731

Texas Oncology - Austin ( Site 1903), Austin

80054

CHU d'Amiens-Picardie - Hôpital Sud-Dermatologie ( Site 1208), Amiens

80131

Istituto Nazionale Tumori IRCCS Fondazione Pascale-s.c. melanoma, immunoterapia oncologica e terapi ( Site 1400), Napoli

80337

Klinik und Poliklinik für Dermatologie und Allergologie-Dermato-oncology ( Site 1315), München

83301

Chang Gung Memorial Hospital at Kaohsiung ( Site 4000), Kaohsiung City

86156

Universitaetsklinikum Augsburg ( Site 1312), Augsburg

90095

UCLA Hematology/Oncology - Westwood (Building 100) ( Site 1918), Los Angeles

94158

UCSF Medical Center at Mission Bay ( Site 1929), San Francisco

94800

Gustave Roussy-Dermatologie ( Site 1201), Villejuif

98109

Fred Hutchinson Cancer Center ( Site 1901), Seattle

111321

Clinica Colsanitas S.A, Sede Clínica Universitaria Colombia-Center Investigator ( Site 2500), Bogotá

230002

IMAT S.A.S ( Site 2503), Montería

760032

Fundación Valle del Lili ( Site 2505), Santiago de Cali

1834111

Emek Medical Center ( Site 2003), Afula

4941492

Rabin Medical Center ( Site 2000), Petah Tikva

5265601

Sheba Medical Center ( Site 2001), Ramat Gan

7500921

FALP-UIDO ( Site 2400), Santiago

7620002

Clínica UC San Carlos de Apoquindo-Hemato-Oncology ( Site 2402), Santiago

8420383

Bradfordhill ( Site 2401), Santiago

9112001

Hadassah Medical Center ( Site 2004), Jerusalem

06510

Yale-New Haven Hospital-Yale Cancer Center ( Site 1933), New Haven

02114

Massachusetts General Hospital ( Site 1927), Boston

02215

Beth Israel Deaconess Medical Center ( Site 1957), Boston

Dana-Farber Cancer Institute ( Site 1956), Boston

07601

John Theurer Cancer Center at Hackensack University Medical Center ( Site 1944), Hackensack

07960

Atlantic Health System ( Site 1925), Morristown

07450

Valley Health Systems - Ridgewood Campus ( Site 1947), Ridgewood

C1430EGF

Clinica Adventista Belgrano-Oncology ( Site 2204), Caba.

C1199ABB

Hospital Italiano de Buenos Aires-Clinical Oncology ( Site 2202), Ciudad Autonoma de Buenos Aires

1426ANZ

Instituto Alexander Fleming-Alexander Fleming ( Site 2203), Buenos Aires

X5800ALB

Centro Privado de RMI Río Cuarto S.A. II ( Site 2201), Río Cuarto

C1118AAT

Hospital Aleman ( Site 2200), Buenos Aires

C1187AAN

Sanatorio Finochietto ( Site 2205), Buenos Aires

30130-090

Centro Avançado de Tratamento Oncológico- CENANTRON ( Site 2303), Belo Horizonte

98700-000

ONCOSITE - Centro de Pesquisa Clinica em Oncologia ( Site 2302), Ijuí

91350-200

Hospital Nossa Senhora da Conceição ( Site 2309), Porto Alegre

20220-410

Instituto Nacional de Câncer - INCA-Pesquisa Clinica HC II ( Site 2305), Rio de Janeiro

01246-000

ICESP - INSTITUTO DO CÂNCER DO ESTADO DE SÃO PAULO ( Site 2300), São Paulo

T6G 1Z2

Cross Cancer Institute ( Site 1104), Edmonton

V5Z 4E6

BC Cancer Vancouver-Clinical Trials Unit ( Site 1106), Vancouver

L6R 3J7

William Osler Health System ( Site 1105), Brampton

M4N 3M5

Sunnybrook Research Institute ( Site 1103), Toronto

M5G 2M9

Princess Margaret Cancer Centre-Division of Medical Oncology and Hematology ( Site 1102), Toronto

H2X 0X9

Centre Hospitalier de l'Université de Montréal-Unité de Recherche Clinique en Oncologie et Hématolo ( Site 1100), Montreal

G1J 1Z4

Centre intégré de cancérologie du CHU de Québec Université L-Hemato-Oncology ( Site 1101), Québec

054040

Clinica Somer-Unidad de Investigacion y Docencia ( Site 2506), Rionegro

06200

Centre Hospitalier Universitaire de Nice - Hôpital l'Archet-Dermatology Department ( Site 1211), Nice

07548

SRH Wald-Klinikum Gera-Zentrum für klinische Studien ( Site 1306), Gera

115 26

"General Hospital of Athens Laiko-First Department of Internal Medicine ( Site 3700)", Athens

185 47

Metropolitan Hospital-A' Oncology Dpt ( Site 3701), Neo Faliro

546 22

Bioclinic Thessalonikis Private Clinic Single Member S.A.-Oncology ( Site 3703), Thessaloniki

570 01

European Interbalkan Medical Center-Oncology Department ( Site 3702), Thessaloniki

06129

AO Santa Maria della Misericordia ( Site 1403), Perugia

466-8560

Nagoya University Hospital ( Site 4201), Nagoya

411-8777

Shizuoka Cancer Center ( Site 4202), Nagaizumi-cho,Sunto-gun

104-0045

National Cancer Center Hospital ( Site 4200), Chūō

60-569

Uniwersytecki Szpital Kliniczny w Poznaniu ( Site 2909), Poznan

85-796

Centrum Onkologii im. Prof. Franciszka Lukaszczyka-Ambulatorium Chemioterapii ( Site 2908), Bydgoszcz

08-110

Mazowiecki Szpital Wojewódzki w Siedlcach-Siedleckie Centrum Onkologii ( Site 2903), Siedlce

02-781

Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy w Warszawie ( Site 2900), Warsaw

15-027

Bialostockie Centrum Onkologii ( Site 2905), Bialystok

80-214

Uniwersyteckie Centrum Kliniczne-Klinika Chirurgii Onkologicznej, Transplantacyjnej i Ogólnej ( Site 2906), Gdansk

44-101

Narodowy Instytut Onkologii - Oddzial w Gliwicach ( Site 2907), Gliwice

71-730

Zachodniopomorskie Centrum Onkologii ( Site 2904), Szczecin

25-734

Swietokrzyskie Centrum Onkologii, Samodzielny Publiczny Zakl-Klinika Onkologii Klinicznej, Dzial Ch ( Site 2902), Kielce

1099-023

Instituto Português de Oncologia de Lisboa Francisco Gentil ( Site 3601), Lisbon

1449-005

Unidade Local de Saude Lisboa Ocidental - Hospital de São Francisco Xavier ( Site 3602), Lisbon

1649-035

Unidade Local de Saude de Santa Maria - Hospital de Santa Maria ( Site 3603), Lisbon

4200-072

Instituto Português de Oncologia do Porto Francisco Gentil, EPE ( Site 3604), Porto

0040

Wilgers Oncology Centre ( Site 4103), Pretoria

03080

Seoul National University Hospital-Oncology ( Site 3902), Seoul

03722

Severance Hospital, Yonsei University Health System-Medical oncology ( Site 3901), Seoul

06351

Samsung Medical Center-Division of Hematology/Oncology ( Site 3900), Seoul

08036

HOSPITAL CLÍNIC DE BARCELONA-ICHMO- Clinic Institut of Haematological and Oncological diseases ( Site 1600), Barcelona

08035

Hospital Universitari Vall d'Hebron-Departamento de Oncologia- VHIO ( Site 1601), Barcelona

413 45

Sahlgrenska Universitetssjukhuset ( Site 3200), Gothenburg

06230

Hacettepe Universite Hastaneleri ( Site 3006), Ankara

06520

Memorial Ankara Hastanesi-Medical Oncology ( Site 3010), Ankara

06800

Ankara Bilkent Şehir Hastanesi-Medical Oncology ( Site 3002), Ankara

BS2 8ED

Bristol Haematology and Oncology Centre ( Site 1811), Bristol

CB2 2QQ

Addenbrooke's Hospital ( Site 1800), Cambridge

NR4 7UY

Norfolk and Norwich University Hospitals NHS Foundation Trust ( Site 1813), Cringleford

NW1 2PG

University College London Hospital ( Site 1807), London

SW3 6JJ

ROYAL MARSDEN HOSPITAL (CHELSEA) ( Site 1804), London

EH4 2XU

Western General Hospital ( Site 1806), Edinburgh

OX3 7LE

The Churchill Hospital ( Site 1805), Oxford

LS9 7TF

St James's University Hospital-Leeds Cancer Centre ( Site 1808), Leeds

m20 4bx

The Christie NHS Foundation Trust ( Site 1814), Manchester

All Listed Sponsors
collaborator

ModernaTX, Inc.

INDUSTRY

lead

Merck Sharp & Dohme LLC

INDUSTRY